MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. GST GOLD RELOAD, 45MM, 6-ROW

Catalog Number GCFRGD

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Failure to Anastomose (1028)

Event Date 08/14/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 1/18/2024.D4: batch # unk.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional information was requested and the following was obtained: was there any other issue noted with the staple line other than leaking (malformed staples, staple line missing staples, etc.)? no.

Event Description

It was reported from a health authority that during after a thoracoscopic left lower bullae and left upper bullae resection, no obvious air leakage was found in the expanded lung during the operation.The patient's chest bottle did not show obvious gas escape on the 1st day after the operation.The patient's chest bottle showed a large amount of gas escape on the 3rd day after the operation.The thoracentesis was performed again to drain the gas.After supportive treatment including closed thoracic drainage and vacuum aspiration, the patient was improved and discharged.

• Brand Name: GST GOLD RELOAD, 45MM, 6-ROW
• Type of Device: GST GOLD RELOAD
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; PR ; 3035526892
• MDR Report Key: 18539958
• MDR Text Key: 333194263
• Report Number: 3005075853-2024-00532
• Device Sequence Number: 1
• Product Code: GST
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: GCFRGD
• Device Lot Number: 309C77
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male